STABILITY INDICATING HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF OFLOXACIN AND FLAVOXATE HYDROCHLORIDE
Objective: The objective of this study was to develop and validate a stability indicating reverse-phase HPLC method for simultaneous estimation of Ofloxacin and Flavoxate hydrochloride from their combination product.
Methods: The proposed RP-HPLC method was developed using inertsil C18, 5 Âµm, 250 mm Ã— 4.6 mm column. The mobile phase used was a mixture of methanol and water in the proportion of 50:50 (v/v) with apparent pH adjusted to 4.9, and UV detection at 274 nm using a PDA detector and Empower-2 software. The flow rate was 1.0 ml/min. Ofloxacin, Flavoxate hydrochloride and their combination drug product were exposed to thermal, photolytic, hydrolytic, and oxidative stress conditions, and the stressed samples were analysed by the proposed method.
Results: With the optimized method, retention times of Ofloxacin and Flavoxate hydrochloride were found to be 4.3 and 2.98 respectively. Peak homogeneity data of Ofloxacin and Flavoxate hydrochloride peaks obtained using PDA detector, in the stressed sample chromatograms demonstrated the specificity of the method for their estimation in the presence of degradants. The described method was linear over a range of 10-60 Âµg/ml with regression coefficient of 0.9996 and 0.9998. The mean recoveries were 99.57% and 99.99% for Ofloxacin and Flavoxate hydrochloride, respectively.
Conclusion: Stress testing, which covered acid, alkali, peroxide, photolytic and thermal degradation was performed to prove the specificity of the proposed method and degradation, was achieved. The developed method was validated according to ICH guidelines and was found to be simple, precise and accurate with the prescribed values.
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